1. Field of the Invention
The invention relates to stable NADH and NADPH compositions which may be taken orally as a therapeutic agent.
2. Description of Related Art
Nicotinamide-adenine-dinucleotide in its reduced form ("NADH") and nicotinamide-adenine-phosphate-dinucleotide in its reduced form ("NADPH") are physiological substances which occur in all living cells including human cells. These substances are cofactors for a variety of enzymes, the majority of which catalyze oxidation-reduction reactions. Prior to recent discoveries as to the therapeutic properties of these compounds, their principal utility has been as diagnostic tools in clinical biochemistry and as essential components in the reaction kits, for example, in measuring Lactatdehydrogenase (LDH).
The most important function of NADH is its driving force for cell respiration. When using oxygen, NADH forms water and 3 ATP molecules in accordance with the following formula: NADH+H.sup.++1/2 O.sub.2+ 3 Pi+3 ATP.fwdarw.NAD.sup.++ 3 ATP+4H.sub.2 O. Thus, with 1 NADH molecule, 3 ATP molecules-are obtained which have an energy of approximately 21 kilocalories. This process is called oxidative phosphorylation. The supply of NADH and/or NADPH makes this work much easier for the organism, because it has greater energy reserves as a result.
More recently, NADH and NADPH and pharmaceutically acceptable salts thereof have been shown to be useful in the treatment of Parkinson's Disease. The effectiveness of these agents for this purpose is documented in my existing U.S. Pat. Nos. 4,970,200 and 5,019,561, the disclosure of which are incorporated herein by reference.
In addition, I have discovered that these substances are effective in the treatment of Morbus Alzheimer (.i-e,, Alzheimer's Disease), as well as in the treatment of mental depression, which is the subject of my co-pending application Ser. No. 07/815,407 filed with the U.S. Patent and Trademark Office on Dec. 31, 1991.
Prior to my recent discoveries, NADH and NADPH have never been considered for therapeutic use, probably because it was believed that these compounds are rather unstable and, hence, not capable of being absorbed by the intestines of the human body. It would have been expected that these substances would be hydrolized in the plasma within a few seconds.
However, studies performed recently using NADH and NADPH demonstrate that these assumptions are incorrect. When NADH and NADPH were applied intravenously to patients with Parkinson's disease, a remarkable beneficial effect was observed which lasted at least 24 hours. See U.S. Pat. Nos. 4,970,200 and 5,019,561. This indicates that NADH and NADPH are not rapidly degraded in the plasma and blood.
One drawback to intravenous application of NADH and NADPH is that it requires an injection which has to be performed in a hospital or at the physician's practice. This requirement can be inconvenient or demanding on the patient's schedule. Therefore, it would be desirable to find a stable oral form for NADH and NADPH which would allow patients to take these substances regularly under their own supervision.